Positive Phase 2 Data from Agenus' Brain Cancer Vaccine Presented at Plenary Session of American Academy of Neurological

Positive Phase 2 Data from Agenus' Brain Cancer Vaccine Presented at Plenary
Session of American Academy of Neurological Surgeons Meeting

Newly Diagnosed Patients With Brain Tumors Treated With Prophage Vaccine Show
Improvement in Progression Free Survival and Overall Survival Compared to
Standard of Care

LEXINGTON, Mass., May 1, 2013 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq:AGEN)
today announced that preliminary data from a Phase 2 clinical trial showed
that newly diagnosed glioblastoma multiforme (GBM) patients treated with
Prophage G-100 (Heat Shock Protein-Peptide Complex-96, HSPPC-96) vaccine plus
the standard of care showed a 146% increase in progression free survival (PFS)
and a 60% increase in overall survival (OS) as compared to the standard of
care alone. Results were presented today by Orin Bloch, M.D., of the
Department of Neurological Surgery, University of California San Francisco
(UCSF), during Plenary Session III at the 81^st American Association of
Neurological Surgeons (AANS) Annual Scientific Meeting in New Orleans,
Louisiana. Dr. Bloch is a lead medical scientist working on the study at UCSF
with Andrew T. Parsa, M.D., Ph.D., lead clinical investigator and study
sponsor. Dr. Parsa is currently at UCSF and will soon join Northwestern
University as the newly appointed Chair of the Department of Neurological

"Cancer vaccines offer the hope of benefit without toxicity for patients with
glioblastoma," said Dr. Parsa. "Data from the HSPPC-96 trials have been
consistently positive in both recurrent and newly diagnosed GBM settings,
supporting the premise that this vaccine may one day become part of the
standard of care. We are now advancing HSPPC-96 in recurrent GBM in the
largest, randomized brain tumor trial ever funded by the NCI and the largest
vaccine study ever conducted with Avastin."

Phase 2 HSPPC-96 Data in Newly Diagnosed GBM Patients

The single-arm, Phase 2 trial of HSPPC-96 in patients with newly diagnosed GBM
included a total of 46 patients treated at eight centers across the United
States. Patients were treated with radiation and temozolomide as the standard
of care in addition to receiving HSPPC-96 vaccination. Analyses of data
collected to date show a median PFS of 17 months; these results compare
favorably to the PFS reported with the standard of care of radiation and
temozolomide alone, which is 6.9 months.^[1]

Median OS, which is the primary endpoint for the trial, in patients treated
with HSPPC-96 is currently 23.3 months. The majority of enrolled patients in
the trial are still being followed and it is expected that PFS and OS will
continue to mature as more data are collected.For the standard of care
involving treatment with radiation and temozolomide alone, median OS survival
is 14.6 months.^[1]

A total of 32 patients enrolled and treated at UCSF also underwent testing for
expression of B7-H1 in blood samples taken prior to surgery.Glioblastoma has
been shown to induce systemic immunosuppression through stimulation of B7-H1
expression, which could affect the efficacy of immunotherapy.These
exploratory analyses showed that patients with low expression of B7-H1 (53%)
had better PFS (21.6 months) than those with high B7-H1 (47%) expression (11.4
months).This finding may have the potential to help identify a more
responsive patient population for future trials.

In addition to the newly diagnosed data presentation at the AANS meeting, the
Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute
(NCI) is supporting a study of the HSPPC-96 vaccine in a large, randomized
Phase 2 trial in combination with bevacizumab (Avastin^®) in patients with
surgically resectable recurrent GBM.The study is being sponsored by the
Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of
the NCI. This study represents the largest brain tumor trial ever funded by
the NCI and the largest vaccine study ever conducted with Avastin.

About the ALLIANCE Trial in Recurrent Glioma

The ALLIANCE trial will investigate the benefits of treatment with a
combination of HSPPC-96 and bevacizumab in a three-arm study of 222 patients
with surgically resectable recurrent GBM using a primary endpoint of overall
survival.The study will compare efficacy of the HSPPC-96 vaccine administered
with bevacizumab either concomitantly or at progression, versus treatment with
bevacizumab alone. This study design is supported in part by previous research
indicating a potential synergistic effect between the mechanisms of action
behind both HSPPC-96 and bevacizumab. For additional information about the
Alliance Trial visit

About the Alliance for Clinical Trials in Oncology at NCI

The Alliance is composed of three NCI funded cooperative groups (American
College of Surgeons Oncology Group [ACOSOG], Cancer and Leukemia Group B
[CALGB], and North Central Cancer Treatment Group [NCCTG]).These three groups
have been integrated in an effort to develop and conduct more efficient
clinical research studies to bring clinical trial results to patients more

The Phase 2 recurrent and newly diagnosed trials are being sponsored by Dr.
Parsa and UCSF and are primarily supported through funding from the American
Brain Tumor Association, Accelerated Brain Cancer Cure, National Brain Tumor
Society, and National Cancer Institute Special Programs of Research
Excellence. Drs. Parsa and Bloch have not received any financial support or
travel expense reimbursement for this work or for consulting activities on
behalf of Agenus and they do not have an equity interest in Agenus or a
financial relationship with the company.

About Glioblastoma Multiforme (GBM)

The incidence rates of primary malignant brain and central nervous system
(CNS) cancers have increased over the last three decades.^[2]The American
Cancer Society estimates that more than 22,000 malignant tumors of the brain
or spinal cord were diagnosed during 2010 in the US and that more than 13,000
people would die from these tumors.Glioblastoma is the most common primary
malignant brain tumor and accounts for the majority of diagnoses.It has been
associated with a particularly poor prognosis, with survival rates at one and
five years equaling 33.7% and 4.5%, respectively.^[3] The current standard of
care for patients with newly diagnosed glioblastoma is surgical resection
followed by fractionated external beam radiotherapy and systemic
temozolomide^[4] resulting in a median overall survival (OS) of 14.6
months^[5] based on data from a randomized Phase III trial.Although this
treatment can prolong survival, it is not curative and the vast majority of
patients with glioblastoma experience recurrent disease, with a median time to
recurrence of seven months.^[6] Currently, there is no standard treatment for
patients with recurrent glioblastoma, although additional surgery,
chemotherapy (i.e., CCNU, temozolomide), bevacizumab, and radiotherapy are

About the Prophage Series Cancer Vaccines

Prophage series cancer vaccines candidates are autologous therapies derived
from cells extracted from the patient's tumor.As a result, Prophage Series
vaccines contain a precise antigenic 'fingerprint' of a patient's particular
cancer and are designed to reprogram the body's immune system to target only
cells bearing this fingerprint, reducing the risk that powerful anti-cancer
agents will target healthy tissue and cause debilitating side effects often
associated with chemotherapy and radiation therapy.The Prophage Series G
vaccines are currently being studied in two different settings of GBM: newly
diagnosed and recurrent disease.

In addition to the newly diagnosed GBM study with G-100 and the ALLIANCE
trial, a Phase 2 study testing the Prophage Series G-200 in patients with
recurrent glioma is underway. Agenus expects the final trial results of this
study to be published in a scientific journal in 2013.

About Agenus

Agenus Inc. is a biotechnology company working to develop treatments for
cancers and infectious diseases. The company is focused on immunotherapeutic
products based on strong platform technologies with multiple product
candidates advancing through the clinic, including several product candidates
that have advanced into late-stage clinical trials through corporate partners.
Between Agenus and its partners, 19 programs are in clinical development. For
more information, please visit www.agenusbio.com.

Forward-Looking Statement

This press release contains forward-looking statements, including statements
regarding potential clinical trial activities, funding sources and timelines.
These forward-looking statements are subject to risks and uncertainties that
could cause actual results to differ materially. These risks and uncertainties
include, among others, the factors described under the Risk Factors section of
our Annual Report on Form 10-K filed with the Securities and Exchange
Commission for the period ended December 31, 2012. Agenus cautions investors
not to place considerable reliance on the forward-looking statements contained
in this release. These statements speak only as of the date of this document,
and Agenus undertakes no obligation to update or revise the statements. All
forward-looking statements are expressly qualified in their entirety by this
cautionary statement. Agenus' business is subject to substantial risks and
uncertainties, including those identified above. When evaluating Agenus'
business and securities, investors should give careful consideration to these
risks and uncertainties.


1. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide
for glioblastoma. N Engl J Med, 2005. 352(10): p. 987-96.

2. Maher EA, McKee AC. In: Atlas of diagnostic oncology. 3. Skarin AT,
Canellos GP, editor. London: Elsevier Science; 2003. Neoplasms of the central
nervous system; pp. 5–10.

3. Central Brain Tumor Registry of the United States (CBTRUS) 2010 CBTRUS
statistical report: primary brain and central nervous system tumors diagnosed
in the United States in 2004-2006. http://www.cbtrus.org/reports/reports.html

4. National Comprehensive Cancer Network clinical practice guidelines in
oncology-central nervous system cancers. v.1.2010.

5. Stupp, R., et al., Radiotherapy plus concomitant and adjuvant temozolomide
for glioblastoma. N Engl J Med, 2005. 352(10): p. 987-96.

6. Wen PY, DeAngelis LM. Chemotherapy for low-grade gliomas: emerging
consensus on its benefits. Neurology. 2007;68(21):1762–1763. doi:

Avastin is a registered trademark of Genentech.

CONTACT: Media and Investor Contact:
         Jonae R. Barnes
         Vice President
         Investor Relations and
         Corporate Communications

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